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Expert Review of Medical Devices Mar 2020: Several handheld thumb ECG devices for on-demand recording of heart rhythm have become available lately. These can be used both by health-care providers and purchased... (Review)
Review
: Several handheld thumb ECG devices for on-demand recording of heart rhythm have become available lately. These can be used both by health-care providers and purchased by laypersons for private use.: This profile describes the Coala Heart Monitor. This device differs from other handheld ECG monitors in three aspects: 1) it records both thumb and chest ECGs, 2) it uses both RR-dispersion and P-wave morphology for detecting atrial fibrillation, and 3) in synchronization with the chest ECG, it also records heart sounds presented as a phonocardiogram making measurement of systolic time intervals possible. The sensitivity and specificity for detecting atrial fibrillation are high. The use of systolic time interval in patients with heart failure has so far not been evaluated.: The increasing use of long-term prescribed and privately owned handheld ECG devices for on-demand recording of heart rhythm will most probably cause a paradigm shift in arrhythmia diagnostics. Coala Heart Monitor´s use of both chest and thumb recordings as well as analyzing both RR-dispersion and P-wave morphology may offer an advantage in diagnosing atrial fibrillation.
Topics: Algorithms; Atrial Fibrillation; Electrocardiography; Equipment and Supplies; Heart Rate; Humans; Monitoring, Physiologic
PubMed: 32101067
DOI: 10.1080/17434440.2020.1732814 -
Clinical Nursing Research Mar 2019Feasibility studies are often the first attempt researchers use to test whether a new process or part of a process is practical for use in a clinical setting or a device...
Feasibility studies are often the first attempt researchers use to test whether a new process or part of a process is practical for use in a clinical setting or a device will provide the desired information. When conducting a device feasibility study there are several unique considerations that must be addressed. This manuscript describes the processes and considerations.
Topics: Biomedical Research; Delirium; Electroencephalography; Equipment and Supplies; Feasibility Studies; Humans; Monitoring, Physiologic
PubMed: 30264584
DOI: 10.1177/1054773818803171 -
Biomedizinische Technik. Biomedical... Apr 2011The high number of false positive alarms has long been known to be a serious problem in critical care medicine - yet it remains unresolved. At the same time, threats to... (Review)
Review
The high number of false positive alarms has long been known to be a serious problem in critical care medicine - yet it remains unresolved. At the same time, threats to patient safety due to missing or suppressed alarms are being reported. The purpose of this paper is to present results from a workshop titled "Too many alarms? Too few alarms?" organized by the Section Patient Monitoring and the Workgroup Alarms of the German Association of Biomedical Engineering of the Association for Electrical, Electronic and Information Technologies. The current situation regarding alarms and their problems in intensive care, such as lack of clinical relevance, alarm fatigue, workload increases due to clinically irrelevant alarms, usability problems in alarm systems, problems with manuals and training, and missing alarms due to operator error are outlined, followed by a discussion of solutions and strategies to improve the current situation. Finally, the need for more research and development, focusing on signal quality considerations, networking of medical devices at the bedside, diagnostic alarms and predictive warnings, usability of alarm systems, education of healthcare providers, creation of annotated clinical databases for testing, standardization efforts, and patient monitoring in the regular ward, are called for.
Topics: Clinical Alarms; Critical Care; Equipment Design; Equipment Failure Analysis; Equipment and Supplies; Monitoring, Physiologic; User-Computer Interface
PubMed: 21366502
DOI: 10.1515/BMT.2011.005 -
Zeitschrift Fur Evidenz, Fortbildung... Aug 2017Missing or false device alarms pose a risk in clinical practice. Publications from the United States suggest that alarm errors are not only caused by technical issues...
Missing or false device alarms pose a risk in clinical practice. Publications from the United States suggest that alarm errors are not only caused by technical issues but to a considerable degree result from user-device interaction problems. To safely operate a medical device, users have to thoroughly understand both device behavior and device functioning. They also need to foresee the exact consequences of their interactions with the device. This can be challenging, especially if a device has multiple functions, is applied in various use contexts or networked with other devices - as is often the case with patient monitors. In this case, human error in operating a device may not necessarily be detected, but is experienced as device failure. If medical device failures occur in German hospitals that are associated with a risk to the patient, the user, or other persons, they have to be reported to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). In the present study, we analyzed reports to the BfArM (received between 01/2009 and 12/2015) about loss or failure of the alarm function of patient monitors. It was found that the perceived 'faulty' behavior of the device was the device's intended behavior in almost half of these reports. Hence, the person who detected this fault was not sufficiently acquainted with the device and/or its configuration. Examples of knowledge deficits related to various aspects of device knowledge. Further studies are needed to find out whether these findings are suggestive of more general knowledge deficits among clinical staff and to explore the underlying reasons.
Topics: Clinical Alarms; Equipment Failure; Germany; Hospitals; Humans; Monitoring, Physiologic; Patient Safety; Risk Management; United States
PubMed: 28642027
DOI: 10.1016/j.zefq.2017.05.028 -
Pharmacoepidemiology and Drug Safety Apr 2020The collection and analysis of real-world data for the active monitoring of medical device performance and safety has become increasingly important. Spontaneous reports,... (Review)
Review
PURPOSE
The collection and analysis of real-world data for the active monitoring of medical device performance and safety has become increasingly important. Spontaneous reports, such as those in the Food & Drug Administration's (FDA's) Manufacturer and User Facility Device Experience (MAUDE), provide early warning of potential issues with marketed devices. This review synthesizes the current literature on medical device surveillance signal detection and provides a framework for application of methods to active surveillance of spontaneous reports.
METHODS
Ovid MEDLINE, Ovid Embase, Scopus, and PubMed databases were systematically searched up to January 2019. Additionally, five methods articles from pharmacovigilance were added that had potential applications to medical devices.
RESULTS
Among 105 articles included, the most common source of data (84%) was registries; median time between data collection and publication was 8 years. Surgical procedure outcome signal detection articles comprised 83% while 14% were on device outcome signal detection. The most common family of methods cited (70%) was Sequential Probability Ratio.
CONCLUSION
Application of any signal detection algorithm requires careful consideration of influential factors, data limitations, and algorithmic assumptions. We recommend approaches using disproportionality, statistical process control, and sequential probability tests and provide R packages to further development efforts. The small number of published examples suggest that further development of statistical methods and technological solutions to analyze large amounts of data for device safety and performance is needed. Fundamental differences in products, data infrastructure, and the regulatory landscape suggest that medical device vigilance requires its own body of research distinct from pharmacovigilance.
Topics: Algorithms; Data Analysis; Databases, Factual; Equipment and Supplies; Humans; Product Surveillance, Postmarketing; Wireless Technology
PubMed: 32128936
DOI: 10.1002/pds.4980 -
Dermatitis : Contact, Atopic,... 2020Multidisciplinary collaboration between several European dermatology departments has identified isobornyl acrylate (IBOA; CAS 5888-33-5), once deemed a low-risk...
Multidisciplinary collaboration between several European dermatology departments has identified isobornyl acrylate (IBOA; CAS 5888-33-5), once deemed a low-risk sensitizer, as a major culprit contact allergen in glucose sensors and insulin pumps, medical devices used by diabetes patients worldwide. Although the patch test modalities of IBOA have been fairly well characterized, intriguing questions remain. For example, its cross-reactive profile to other acrylates remains to be determined, and the striking occurrence of concomitant positive patch test reactions to sesquiterpene lactones needs to be further elucidated. Importantly, the path to its discovery as a contact sensitizer in diabetes devices and the difficulties that were associated with this quest illustrate that apparent difficulties in obtaining sufficient cooperation from the medical device industry may seriously hamper the correct workup of cases of allergic contact dermatitis. The IBOA saga will convince companies to lend more cooperation to dermatologists and policymakers to side with patients and physicians when it comes to updating medical device regulations, including the compulsory labeling of medical devices in general and of diabetes devices in particular.
Topics: Acrylates; Allergens; Blood Glucose Self-Monitoring; Camphanes; Cross Reactions; Dermatitis, Allergic Contact; Equipment and Supplies; Humans; Insulin Infusion Systems; Lactones; Manufacturing Industry; Patch Tests; Product Labeling; Sesquiterpenes
PubMed: 31913984
DOI: 10.1097/DER.0000000000000549 -
Current Cardiology Reports Nov 2019This review describes the novel category of wearable ECG monitors and identifies where patients, healthcare providers, and device manufacturers should focus efforts to... (Review)
Review
PURPOSE OF REVIEW
This review describes the novel category of wearable ECG monitors and identifies where patients, healthcare providers, and device manufacturers should focus efforts to maximize the clinical benefit of these devices.
RECENT FINDINGS
Notable wearable ECG monitors include the AliveCor Kardia devices, Apple Watch Series 4, and several others. The most common use case is monitoring for atrial fibrillation. The available evidence validates the ability of the Kardia devices and Apple Watch to distinguish atrial fibrillation from sinus rhythm. Key questions for manufacturers include how to calibrate each device's algorithms and streamline workflows for healthcare providers. Wearable ECG monitors are currently most useful to detect atrial fibrillation. Further study is needed to demonstrate whether wearable ECG monitors improve patient outcomes, and to expand their use into other indications. Device manufacturers and healthcare providers must work together to establish new workflows to process and act on wearable ECG data.
Topics: Atrial Fibrillation; Electrocardiography, Ambulatory; Humans; Mobile Applications; Wearable Electronic Devices
PubMed: 31768764
DOI: 10.1007/s11886-019-1223-8 -
Diagnostic and Interventional Radiology... Jul 2018Cardiovascular devices and hemodynamic monitoring systems continue to evolve with the goal of allowing for rapid clinical intervention and management. Cardiovascular... (Review)
Review
Cardiovascular devices and hemodynamic monitoring systems continue to evolve with the goal of allowing for rapid clinical intervention and management. Cardiovascular devices including the CardioMicroelectromechanical (CardioMEMS) device, implantable loop recorder, and right ventricular (RV) leadless pacemaker are now widely used for treatment and monitoring of advanced cardiac conditions, as many of these devices have been shown to significantly improve patient outcomes. Additionally, hemodynamic monitoring devices have shown utility in monitoring patients with aortic aneurysms after endovascular aortic repair (EVAR) for early detection of Type I and Type II endoleaks. There is limited published data regarding the imaging features of these devices. As these devices become more widely used, it is important for radiologists to become familiar with the normal imaging features and potential complications. The goal of this review is to summarize the data regarding the use of leadless cardiovascular devices including the CardioMEMS device, implantable loop recorder, and RV leadless pacemaker, and to present cases demonstrating their utility and normal imaging features.
Topics: Equipment Design; Equipment and Supplies; Humans; Monitoring, Physiologic; Pacemaker, Artificial; Radiography; Tomography, X-Ray Computed
PubMed: 30091710
DOI: 10.5152/dir.2018.17462 -
The Journal of Allergy and Clinical... 2015Use of electronic monitoring devices (EMDs) for inhalers is growing rapidly because of their ability to provide objective and detailed adherence data to support clinical... (Review)
Review
Use of electronic monitoring devices (EMDs) for inhalers is growing rapidly because of their ability to provide objective and detailed adherence data to support clinical decision making. There is increasing potential for the use of EMDs in clinical settings, especially as cost-effectiveness is realized and device costs reduce. However, it is important for clinicians to know about the attributes of different EMDs so that they can select the right device for their patients and understand the factors that affect the reliability and accuracy of the data EMDs record. This article gives information on where to obtain EMDs, describes device specifications, and highlights useful features for the clinician and the patient, including user feedback data. We discuss the benefits and potential drawbacks of data collected by EMDs and provide device users with a set of tools to optimize the use of EMDs in clinical settings, such as advice on how to carry out brief EMD checks to ensure data quality and device reliability. New EMDs on the market require pretesting before use by patients. We provide information on how to carry out EMD pretesting in the clinic and patients' homes, which can be carried out by health professionals or in collaboration with researchers or manufacturers. Strategies for interpreting and managing common device malfunctions are also discussed.
Topics: Administration, Inhalation; Device Approval; Drug Administration Schedule; Equipment Design; Equipment Failure; Humans; Medication Adherence; Nebulizers and Vaporizers; Pharmaceutical Preparations; Practice Guidelines as Topic; Remote Sensing Technology; Reproducibility of Results; Signal Processing, Computer-Assisted; Time Factors; United States; United States Food and Drug Administration
PubMed: 25840665
DOI: 10.1016/j.jaip.2015.01.024 -
American Journal of Infection Control Jun 2019The complexity of medical devices has increased over the past 10 years, and outbreaks of infections due to contaminated devices have focused attention on the need to... (Review)
Review
The complexity of medical devices has increased over the past 10 years, and outbreaks of infections due to contaminated devices have focused attention on the need to adequately clean medical devices in order to ensure the adequacy of disinfection and sterilization. There has been a paradigm shift in reprocessing of medical devices, with increased emphasis on a quality management systems approach that requires validated cleaning instructions from manufacturers and ongoing monitoring by reprocessing personnel to ensure adequacy of cleaning. This article reviews the current issues related to medical device reprocessing and summarizes the approaches used for monitoring cleaning efficacy for surgical instruments and flexible endoscopes.
Topics: Decontamination; Disease Transmission, Infectious; Disinfection; Equipment and Supplies; Fomites; Humans; Quality Control
PubMed: 31146843
DOI: 10.1016/j.ajic.2019.02.029